This page provides an independent statistical analysis and educational interpretation of publicly reported results. ClinicalTrials.gov provides the official trial registry record. Numerical trial results on this page are restricted to the results posted in the ClinicalTrials.gov record; calculations added by Clinical Biostats are labelled as such.
1. Trial at a Glance
This page covers the registry results for Mental Health Support for Transgender and Gender-expansive Individuals (NCT06229132), a na na study. The primary outcome is Depression: Score on the Overall Depression Severity & Impairment Scale (ODSIS).
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT06229132 |
| Phase | NA |
| Condition | Transgender, Depression, Anxiety |
| Allocation | Not applicable (single group) |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 25 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Columbia University |
| Results posted | Yes |
2. Clinical Question
Population
The study focused on Romanian transgender and gender-diverse individuals who reported depression or anxiety. The primary-outcome description states that 25 participants completed baseline measures; 22 completed the 5-month follow-up. Data for that outcome were not collected from the 3 participants who did not complete follow-up.
Intervention
The intervention was LGBTQ-affirmative cognitive behavioral therapy (CBT), delivered by trained therapists through Zoom. The brief summary describes 16 1-hour sessions based on 6 principles, including addressing LGBTQ-related stress, supporting cognitive flexibility and self-expression, recognizing strengths, and attending to intersecting identities.
Comparator
This was a single-group study, with no like-for-like control group described. The registry lists allocation as NA and masking as none. The study therefore does not provide a randomized comparison of the intervention against another treatment or a control condition.
Primary question
The primary outcome was depression severity and impairment measured using the Overall Depression Severity & Impairment Scale (ODSIS). Scores were planned at baseline and 5 months post-baseline. The study was intended to evaluate feasibility, acceptability and efficacy potential; the registry record does not report the outcome means, standard deviations, or an analysis comparing measurement times.
3. Trial Design
This completed study evaluated LGBTQ-affirmative CBT in a single group of transgender and gender-diverse participants. The registry lists the study model as single-group, allocation as NA, and masking as none. There is no randomized control group in the record, so the design is suited to describing participants' experience and changes over time, not to isolating an intervention effect from other explanations for change.
The brief summary describes a remote intervention of 16 1-hour sessions delivered by trained therapists on Zoom. Its approach was based on 6 LGBTQ-affirming CBT principles: normalizing mood and anxiety in relation to LGBTQ-related stress; addressing persistent stress-related cognitions; encouraging assertive behavior and self-expression; validating clients' strengths; supporting authentic relationships; and recognizing intersectional identities as potential sources of stress and resilience.
The record identifies depression as the primary outcome, assessed with the ODSIS at baseline and 5 months post-baseline. It also lists anxiety, psychological distress, suicidal ideation, hazardous drinking, anticipated and internalized stigma, gender identity rumination, and pride among the secondary outcomes. The record lists 14 outcome measures overall, but no analyses. Its phase is recorded as NA. The sponsor is Columbia University.
The study started on 2022-03-15, had a primary completion date of 2022-12-31, and is marked completed. The registry record does not report a randomized allocation procedure, a masking procedure, or a comparison group. It also does not report the protocol details needed to determine how treatment attendance, intervention fidelity, or feasibility and acceptability were evaluated.
4. Participant Flow and Accounting
The registry reports how participants moved through each stage of the study. All counts below are exactly as posted; missing counts are not inferred from other stages.
Overall Study
| Stage | TGE Individuals |
|---|---|
| STARTED | 25 |
| COMPLETED | 22 |
| NOT COMPLETED | 3 |
Analysis population for the primary outcome, as defined in the registry: 25 participants completed baseline measures, and 22 participants completed the 5-month follow up. Data for this outcome measure was not collected from those 3 participants who did not complete the 5-month follow up.
5. Baseline Characteristics
The table reproduces the baseline characteristics posted in the registry, which describe the participants analysed at baseline and help show whether the randomized groups were comparable.
| Characteristic | Unit | TGE Individuals |
|---|---|---|
| Participants analysed | 25 | |
| Age, Continuous | years | 25.16 (SD 6.39) |
| Sex/Gender, Customized: Female | Participants | 13 |
| Sex/Gender, Customized: Male | Participants | 10 |
| Sex/Gender, Customized: Intersex | Participants | 2 |
| Race/Ethnicity, Customized: Romanian | Participants | 21 |
| Race/Ethnicity, Customized: Roma | Participants | 1 |
| Race/Ethnicity, Customized: Other | Participants | 3 |
| Region of Enrollment: Romania | participants | 25 |
| Gender identity: Transgender woman | Participants | 11 |
| Gender identity: Transgender man | Participants | 10 |
| Gender identity: Nonbinary (e.g., genderqueer, agender, gender fluid) | Participants | 4 |
| Sexual orientation: Bisexual | Participants | 5 |
| Sexual orientation: Demisexual | Participants | 1 |
| Sexual orientation: Gay | Participants | 1 |
| Sexual orientation: Heterosexual | Participants | 8 |
| Sexual orientation: Pansexual | Participants | 4 |
| Sexual orientation: Queer | Participants | 6 |
| Educational attainment: High school or less | Participants | 12 |
| Educational attainment: Some college | Participants | 4 |
| Educational attainment: College degree | Participants | 7 |
| Educational attainment: Graduate degree | Participants | 2 |
6. Primary Endpoint
The registry lists the primary outcome as Depression: Score on the Overall Depression Severity & Impairment Scale (ODSIS), measured over Measured at baseline and 5 months post-baseline.
| Element | Registry entry |
|---|---|
| Result type | Mean |
| Measure of spread | Standard Deviation |
| Unit | score on a scale |
| Endpoint classification | Continuous Endpoint |
The primary endpoint is depression severity and impairment measured with the Overall Depression Severity & Impairment Scale (ODSIS). It asks about the past week and covers symptom frequency, severity, and impairment related to depression. The instrument has five items, each scored on a five-point scale from 0, indicating no depression in the past week, to 4, indicating constant depression. The item scores are summed to form a total score from 0 to 20. Higher scores indicate greater depressive symptoms, which the registry describes as a worse outcome.
A structured scale can provide a consistent way to characterize symptoms and impairment across participants and measurement times. Measuring at baseline and 5 months post-baseline allows a descriptive assessment of scores over time. In a single-group study, however, a change in scores cannot by itself establish that the intervention caused the change. Other influences, including changes over time or differences in who provides follow-up data, may also matter.
The registry record describes the measurement schedule and scoring but does not report the baseline or follow-up mean, standard deviation, change estimate, confidence interval, or statistical test. Consequently, the magnitude and precision of any change in ODSIS scores cannot be assessed from the registry results described in this record.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record identifies a completed, single-group study designed to examine feasibility, acceptability, and efficacy potential for remote LGBTQ-affirmative CBT among Romanian transgender and gender-diverse individuals reporting depression or anxiety. It specifies depression measured by the ODSIS as the primary outcome. These design details clarify what the study set out to assess, but they are not evidence of an observed treatment effect.
The primary outcome was scheduled at baseline and 5 months post-baseline. The record states that 25 participants completed baseline measures and 22 completed the 5-month follow-up. It also states that outcome data were not collected from the 3 people who did not complete follow-up. The registry record does not report the ODSIS means or standard deviations at either time, a change estimate, a confidence interval, or a statistical test. Without those results, the direction, magnitude, and precision of the observed score pattern cannot be described.
The record lists 14 outcome measures and no analyses. It names several secondary domains, including anxiety, psychological distress, suicidal ideation, hazardous drinking, and measures of gender minority stress and resilience. Listing an outcome does not establish that results were collected, analyzed, or reported. The registry record does not report numerical results for those outcomes in the registry record in this record.
Because there is no control group, any before-and-after difference, if reported elsewhere, would describe change among participants rather than a controlled contrast. A single-group comparison cannot separate intervention-related change from other causes, such as natural fluctuation, concurrent experiences, or the effects of participating in a study. In addition, follow-up data are absent for some participants, so estimates based only on those with follow-up could reflect the outcomes of that subset rather than everyone who started.
These limitations do not negate the study's stated feasibility and acceptability aims. They define what can be inferred from the available registry information. The record describes an intervention and planned outcome assessments, but it does not supply the numerical outcome results needed to evaluate symptom trajectories or their uncertainty. No conclusion about benefit or lack of benefit follows from the absence of reported estimates.
9. Statistical Methods Explained
The record describes a continuous primary outcome: an ODSIS total score, summarized as a mean with a standard deviation. A mean describes the average score in a group. A standard deviation describes how dispersed individual scores are around that average. These are descriptive statistics; neither alone establishes whether a change is attributable to an intervention.
What does a baseline-to-follow-up comparison tell us?
In a repeated-measures design, the same participants can be assessed at more than one time. Comparing their scores can describe how measurements vary over time. A statistical analysis might estimate average change, but the registry record does not report such an estimate or specify the analysis used. In a single-group design, an observed change is not a controlled treatment contrast. Without a comparison group, the data cannot distinguish intervention-related change from other influences on participants' scores.
How should uncertainty be interpreted?
A confidence interval is a general statistical way to express uncertainty around an estimated quantity. It gives a range of values compatible with the data and the assumptions of the analysis. Narrower intervals generally indicate greater precision, while wider intervals indicate less precision. The registry record does not report a confidence interval for the primary outcome, so the precision of an estimated change cannot be evaluated. A p-value, if reported, would address compatibility with a specified statistical null model; it would not by itself convey the size or practical importance of an effect. No primary-outcome p-value is reported in the registry record.
Why does follow-up completeness matter?
Follow-up measurements are needed to describe outcomes at the later assessment. The record reports baseline measures for 25 participants and 5-month follow-up for 22, with outcome data not collected from the 3 who did not complete follow-up. When follow-up is incomplete, a complete-case summary describes those with observed measurements. Its relevance to everyone who began the study depends in part on why measurements are missing and how outcomes among participants without follow-up might differ. The registry record does not report reasons for missing follow-up, a missing-data method, or an analysis population definition.
In general, statistical methods for missing data rely on assumptions. For example, some approaches use observed information to estimate missing outcomes, while others analyze only participants with complete measurements. These approaches can produce different results, and their suitability depends on study details. The record does not identify which approach, if any, was used for the primary endpoint.
What can a single-group design establish?
A within-group measurement over time can describe temporal change. It cannot provide the same causal evidence as a randomized comparison, because there is no concurrent control group to represent what might have happened without the intervention. This is a design limitation, not a statistical calculation that can be corrected by a more elaborate analysis. The registry lists no allocation and no masking, consistent with the single-group description.
How do the planning illustrations relate to the study?
The planning assumptions describe a hypothetical two-arm calculation using equal allocation, a two-sided significance level of 0.05, and a normal approximation, with the target effect expressed as a fraction of an observed effect. Such calculations are planning illustrations, not observed power. The registry entries do not give the underlying effect estimate or numerical planning results, so neither the assumed effect nor the resulting participant requirements can be evaluated. The hypothetical equal-allocation setup is not the study's actual single-group design.
More broadly, a statistical plan would ordinarily clarify the primary analysis, treatment of repeated measurements, missing-data assumptions, and how secondary outcomes are handled. Those details are not reported in the registry record. The record lists 14 outcome measures and no analyses, so it does not establish which models or tests were used, whether estimates were adjusted, or whether any sensitivity analyses were conducted. These omissions limit reproducibility and the assessment of uncertainty, but they do not imply that a particular method was or was not used outside the registry record.
10. Multiplicity, Missing Data and Analysis Populations
The registry record lists 14 outcome measures, including the primary ODSIS depression measure and secondary measures addressing anxiety, distress, suicidal ideation, hazardous drinking, stigma, rumination, and pride. When a study assesses multiple outcomes, testing each one can increase the chance that at least one result appears statistically notable by chance. General approaches to this issue include identifying a primary outcome in advance, adjusting inference across tests, or treating secondary findings as exploratory. The registry record does not report a multiplicity strategy or specify how the secondary measures were to be interpreted.
The record lists no analyses. It therefore does not report which outcomes were analyzed, the statistical tests or models used, or whether adjustments for multiple comparisons were made. The absence of reported analyses should not be read as evidence that no analysis occurred; it means the registry information does not document one.
For the primary outcome, baseline measures were completed by 25 participants and 5-month follow-up by 22. Data for the ODSIS were not collected from the 3 participants who did not complete follow-up. The record does not state why follow-up measurements were unavailable, whether missingness was related to participants' outcomes, or how missing data were handled analytically. It also does not define an analysis population, such as whether analyses were intended to include all enrolled participants or only those with measurements at both times. Those details matter when interpreting any estimate based on observed follow-up data.
11. Safety Results
The registry reports serious adverse events as affected participants divided by participants at risk.
| Arm | Participants with serious adverse events | Participants at risk | Percentage |
|---|---|---|---|
| TGE Individuals | 5 | 25 | 20.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| TGE Individuals | 0 of 25 |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 0% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| TGE Individuals | 0 of 25 |
Most frequent serious adverse event terms
| Event term | Organ system | TGE Individuals |
|---|---|---|
| Suicidal ideation | Psychiatric disorders | 5 of 25 |
Serious events with the highest arm-level rate: suicidal ideation (20.0%).
The registry lists serious adverse events for the group titled TGE Individuals. It reports 25 participants at risk, 5 with serious adverse events, 0 with other adverse events, and 0 deaths. The listed top serious-event term is suicidal ideation, with 20.0% shown. These entries describe what was recorded in the registry; they do not establish that the intervention caused an event or that an event was caused by something else.
Serious adverse-event counts and outcome-scale scores answer different questions. The ODSIS measures depression symptoms and impairment, while adverse-event reporting records events classified as serious under the study's reporting process. A serious-event listing does not substitute for an analysis of symptom change, and an outcome score does not provide a complete account of safety.
The registry record does not provide further detail about event timing, duration, severity beyond the serious classification, relationship to the intervention, or how events were assessed. It also does not give a comparison group for contextualizing event frequency. The reported counts should therefore be read as descriptive entries from this single-group study, without causal attribution.
12. What the Result Does, and Does Not, Mean
The record documents a completed study of remote LGBTQ-affirmative CBT for Romanian transgender and gender-diverse participants reporting depression or anxiety. It identifies depression severity and impairment measured by ODSIS as the primary outcome, with measurement planned at baseline and 5 months post-baseline. It also describes a broader set of secondary measures and reports serious adverse-event entries.
Those design and registry entries do not reveal the primary outcome result. The registry record does not report ODSIS means, standard deviations, an estimate of change, a confidence interval, or an analysis. It is therefore not possible from this record to say whether scores increased or decreased, how large any change was, or how precisely it was estimated. This absence of results is not evidence that the intervention did or did not affect depression symptoms.
Even if a before-and-after difference were available, the single-group design would not establish that the intervention caused it. A control group helps distinguish change associated with an intervention from change that might occur for other reasons. Without such a comparison, causal interpretation is limited. Incomplete follow-up also means that later measurements are unavailable for some participants, and the registry does not describe why or how missing measurements were handled.
The study's stated focus on feasibility, acceptability, and efficacy potential is relevant to its purpose. Such aims can inform whether an intervention and its assessment are practicable and can guide later research. The registry record, however, does not report the numerical findings needed to judge those aims. The results described in the record support a clear account of the study design and measurement plan, but not a conclusion about effectiveness or the size of any symptom change.
13. Why This Trial Matters Statistically
This study is statistically informative as an example of the distinction between a study's question, its design, and the evidence available for interpretation. It planned repeated measurement of depression symptoms in a population identified in the registry as transgender and gender-diverse individuals reporting depression or anxiety. It also described a structured remote intervention and a set of secondary measures spanning mental health and gender minority stress and resilience.
The single-group design can describe participants' measurements over time, but it does not create a concurrent counterfactual comparison. That distinction matters when interpreting change: a score difference over time, if reported, would not by itself show that the intervention produced it. This is a design constraint, rather than an issue that can be resolved solely by choosing a more complex statistical model.
Follow-up data availability is also central. The record reports baseline and 5-month completion counts for the primary outcome, and says data were not collected from those who did not complete follow-up. Without reasons for missing measurements or a documented analysis approach, readers cannot assess how missingness may affect an estimate.
Finally, the registry identifies many outcome measures but does not report analyses or numerical primary-outcome results. Clear reporting of estimates and uncertainty, alongside methods for repeated measurements, missing data, and multiple outcomes, would allow readers to judge what the results support. The record's design and outcome plan are informative, but the lack of reported analysis results limits statistical interpretation.
14. Limitations
- The posted summary statistics are the only data these results rest on; patient-level data, full protocols and statistical analysis plans are not available.
- Recalculated results are simple, unadjusted calculations from posted summaries. They do not replace the sponsor's prespecified analysis.
Several limitations follow directly from the study design and information recorded. First, this was a single-group study without a control comparison. Any observed change over time could not be separated from other influences using a randomized contrast. The record lists allocation as NA and masking as none.
Second, outcome data were not collected at 5-month follow-up for 3 participants who did not complete that assessment. The registry record does not report why they did not complete follow-up or whether their outcomes might differ from those with observed data. It also does not identify a missing-data method or analysis population.
Third, the registry record does not report the primary outcome means, standard deviations, change estimate, confidence interval, or statistical test. It lists 14 outcome measures and no analyses, and does not describe a multiplicity strategy. Readers therefore cannot evaluate the size or precision of the primary outcome pattern, or determine how secondary outcomes were analyzed.
Finally, the information recorded does not fully describe implementation or delivery. The brief summary specifies remote sessions and trained therapists, but the registry record does not report participant attendance, adherence, intervention fidelity, or detailed feasibility and acceptability results. These omissions constrain assessment of how the intervention was delivered and how complete the planned evaluation was.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Mental Health Support for Transgender and Gender-expansive Individuals — NCT06229132.
- Registry record last updated 2025-09-16; status last verified 2025-08.
- Results first posted 2025-09-16.
- Data retrieved from ClinicalTrials.gov on 2026-11-09.
- Group sizes, means, event counts and sponsor-reported p-values are reproduced as posted. Effect estimates, confidence intervals and p-values not attributed to the sponsor are independently calculated from the posted summary statistics.
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18. Record Summary
The registry describes a completed, single-group study titled “Mental Health Support for Transgender and Gender-expansive Individuals,” sponsored by Columbia University. The study focused on Romanian transgender and gender-diverse individuals reporting depression or anxiety and evaluated LGBTQ-affirmative CBT delivered by trained therapists through Zoom. The brief summary describes 16 1-hour sessions based on 6 affirming principles.
The primary outcome was ODSIS depression severity and impairment, measured at baseline and 5 months post-baseline. The record states that 25 participants completed baseline measures and 22 completed follow-up; data were not collected from the 3 participants who did not complete follow-up. It lists 14 outcome measures and no analyses. Numerical primary-outcome results and the statistical analysis plan are not reported in the registry record.
The study is marked completed, with a start date of 2022-03-15 and primary completion date of 2022-12-31. The single-group design does not provide a randomized control comparison.